As a result of the recent green light for UK scientists to start genetically modifying human embryos, genome editing is hitting the headlines once again. Here we take a look at some recent IP activities relating to the CRISPR patents.
The ability of the CRISPR/Cas9 system to make precisely targeted mutations in genes, including human genes, has taken the biotech industry by storm. It has been described by some as being the most important development in biology since the discovery of the structure of DNA by Watson and Crick in 1953.
The two main players in this field - Feng Zhang of the Broad Institute (US) and Jennifer Doudna of the University of California (US) – both recognised the potential value of this technology, and filed patent applications with claims to it. The Broad Institute had the foresight to file requests at both the US Patent & Trademark Office (USPTO) and the European Patent Office (EPO) for accelerated patent examination. Consequently, over the past 2 years, the Broad Institute has had 12 US patents and 4 European patents granted covering the CRISPR gene-editing technology. Last year, Editas Medicine was given an exclusive licence by the Broad Institute to use these patents for human therapy and, following this, investors poured US$120 million into Editas. However, although the Broad Institute may have won the race to get CRISPR patents granted first, and to start exploiting those patents, that is not the end of the story.
In Europe, the first two of the Broad Institute’s EP patents have now been opposed by 9 and 8 parties, respectively, including Novozymes A/S and CRISPR Therapeutics AG. These “Oppositions” assert that the EP patents should never have been granted. The Broad Institute has just been set a deadline by the EPO for filing a written reply to the 9 Oppositions against their first EP patent. Ultimately, a hearing will be held at the EPO with all parties being given an opportunity to present their cases verbally, after which the EPO will decide on the merits of the Oppositions. Inevitably, however, the losing party (or parties) are likely to file an Appeal; and hence it could well be 3-5 years or more before these issues are resolved. The final result will be that one or more of the Broad Institute’s EP patents are maintained in their current form, their claims are restricted in scope, or the whole patents are revoked.
In the US, different challenges are being made. Whilst the Broad Institute has 12 granted US patents, Jennifer Doudna and the University of California have a US patent application with an earlier filing (priority) date. Hence the question in the US is: who has the earliest patent application which adequately describes the CRISPR invention? (Such proceedings are known as “interference proceedings” in the US.) After a year of being pestered by the University of California’s patent attorneys, the US Examiner finally accepted that there was an issue to be resolved here and the USPTO declared an “interference” on 11 January 2016 between the University of California’s US patent application and the Broad Institute’s 12 US patents. A panel of three patent judges will now be appointed to hear the interference, to receive the parties’ written briefs and possibly even to hear the inventors’ oral testimonies; and ultimately to make a decision on this matter. Of course, any losing party may file an Appeal to the US courts, and so the final US answer may take a few years to arrive.
So, until these issues are finally decided, the answer to the question “who owns the rights to the CRISPR genome-editing technology?” in Europe and the US (and we could get different answers in these two territories) will remain unresolved.